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Quality Access® HCG Test Cassette (Urine) - Indonesia BPOM Medical Device Registration

Quality Access® HCG Test Cassette (Urine) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101422264. The device is manufactured by NANTONG EGENS BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is BUANA MITRA SUKSES.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : B
Quality Access® HCG Test Cassette (Urine)
Analysis ID: AKL 20101422264

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

BUANA MITRA SUKSES

AR Address

RUKO NIAGA KALIMAS I BLOK B 10-11 JL INSPEKSI KALIMALANG

Registration Date

Nov 01, 2024

Expiry Date

Aug 08, 2026

Product Type

Clinical Chemistry Test System

Human chorionic gonadotropin (HCG) test system (strip & midstream)

Invitro Diagnostics

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